Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-02-25 @ 8:51 PM
Study NCT ID:
NCT02732392
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2016-03-30', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of sentinel nodes radiolabeled', 'timeFrame': '54 months', 'description': 'Number of sentinel nodes radiolabeled radiolabeled in the area of standard cleaning'}, {'measure': 'Number of sentinel nodes radiolabeled', 'timeFrame': '54 months', 'description': 'Number of sentinel nodes radiolabeled outside the standard cleaning of territory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patient With Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '36331157', 'type': 'DERIVED', 'citation': 'Lannes F, Baboudjian M, Ruffion A, Rouy M, Giammarile F, Rousseau T, Kraeber-Bodere F, Rousseau C, Rusu D, Colombie M, Brenot-Rossi I, Rossi D, Mottet N, Bastide C. Radioisotope-guided Lymphadenectomy for Pelvic Lymph Node Staging in Patients With Intermediate- and High-risk Prostate Cancer (The Prospective SENTINELLE Study). J Urol. 2023 Feb;209(2):364-373. doi: 10.1097/JU.0000000000003043. Epub 2022 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is a very important element in the coverage (care). He allows to determine the local extension of the disease and the type(chap) of therapeutics to implement(operate) after the surgery. The standard cleaning out at present recommended by the European company (society) of urology at the patients at intermediate or high risk of second offense (recurrence) after local treatment(processing), has to concern the obturating pit, the internal and external iliac territories. However this type(chap) of cleaning out does not seem to solve all the problems of locoregional stratification. Indeed, several studies concerning the radio-controlled cleaning out highlighted that 10 in 30% of ganglions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject man, whose age is greater than or equal to 18 years\n* Carrier of cancer intermediate risk non-metastatic prostate or high relapse\n* Subject with an initial balance sheet expansion, regional and general negative by Scanner, abdominopelvic MRI or bone scan,\n* Subject has undergone a medical examination in connection with the study,\n* Topic for which a radical prostatectomy is considered curative purposes,\n* Supported by Subject surgical teams involved in the study,\n* Topic affiliated to a social security scheme,\n* Subject who signed informed consent.\n\nExclusion Criteria:\n\n* Subject man, whose age is less than 18 years\n* Subject who have received hormone therapy or radiation therapy for prostate cancer\n* Subject who had surgery for prostate adenoma (transurethral resection or open surgery) because of potential difficulties injection of radioactive tracer in the gland,\n* Subject has a history of pelvic surgery or radiotherapy,\n* Subject with inguinal hernia repair history of laparoscopic,\n* Subject refusing blood transfusions,\n* Subject is not agreeing to participate in this study and did not sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT02732392', 'acronym': 'SENTINELLE', 'briefTitle': 'Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer', 'orgStudyIdInfo': {'id': '2012-07'}, 'secondaryIdInfos': [{'id': '2012-A-000287-36', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lymphadenectomy', 'interventionNames': ['Procedure: standard lymphadenectomy', 'Procedure: lymphadenectomy radio-isotope method']}], 'interventions': [{'name': 'standard lymphadenectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['lymphadenectomy']}, {'name': 'lymphadenectomy radio-isotope method', 'type': 'PROCEDURE', 'armGroupLabels': ['lymphadenectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}